Continues to Press Northwestern University on Heart Valve Disclosures
WASHINGTON – Sen. Chuck Grassley of Iowa continues to press Northwestern University on whether the university withheld key documents in an earlier inquiry into whether a cardiologist used an unapproved heart-valve repair device on patients without their proper consent.
“Moreover, the … documents which you belatedly disclosed bear directly on the question that precipitated my investigation in 2008 and remains unanswered: did Northwestern implant an unapproved device — which it knew, or should have known, required approval — in patients without obtaining their informed consent?” Grassley writes in an April 28 letter to the presidents of Northwestern University and Northwestern Memorial Hospital.
Grassley wrote to Northwestern last month after new information came to light about documents on the Myxo Ring that Northwestern did not disclose to him in 2009. Northwestern responded and claimed Grassley staff agreed to a limited document production then. However, Grassley’s correspondence at the time made clear he sought all documents on the Myxo Ring. Grassley’s April 28 letter seeks any documentation of any agreement to limit the document production. In addition, the letter asks how the university reconciled the cardiologist’s description of the Myxo Ring as “significantly larger than existing commercial remodeling rings” with the device maker’s assurance that the device was merely a “minor modification” of an existing device. The distinction is critical to whether FDA approval of the device was necessary before use in patients and whether patients were required to give informed consent to receive the device.
Grassley’s March 4 letter to Northwestern is available here.
Northwestern’s March 21 response is available here.
Grassley’s April 28 letter to Northwestern is available here.